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CTRI Number  CTRI/2019/04/018448 [Registered on: 08/04/2019] Trial Registered Prospectively
Last Modified On: 04/04/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of standard exercise protocol versus physical activity counselling on blood sugar control and outcome of pregnancy in women diagnosed with gestational diabetes mellitus 
Scientific Title of Study   Effects of standard antenatal exercise protocol versus physical activity counselling on glycemic control and perinatal outcome in women diagnosed with gestational diabetes mellitus: Randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chandana Vidya Shankar 
Designation  Junior resident  
Affiliation  Kasturba Medical College, Manipal 
Address  Department of OBG Kasturba Medical College, Manipal Udupi
Kasturba Medical College, Manipal Udupi
Udupi
KARNATAKA
576 104
India 
Phone  8105601617  
Fax    
Email  chandanavidyashankar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Akhila Vasudeva 
Designation  Professor  
Affiliation  Kasturba Medical College, Manipal 
Address  Department of OBG Kasturba Medical College, Manipal Udupi
Kasturba Medical College, Manipal Udupi
Udupi
KARNATAKA
576 104
India 
Phone  9591614792  
Fax    
Email  akhilavasudeva@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrRoopa 
Designation  Associate Profesor  
Affiliation  Kasturba Medical College, Manipal 
Address  Department of OBG KMC Manipal

Udupi
KARNATAKA
576104
India 
Phone  9008415729  
Fax    
Email  roopasarun@gmail.com  
 
Source of Monetary or Material Support  
Self funded - Primary Investigator Dr.Chandana Vidya Shankar Department of OBG Kasturba Medical College, Manipal Udupi Karnataka 
 
Primary Sponsor  
Name  DrChandana Vidya Shankar 
Address  Department of OBG Kasturba Medical College Manipal Udupi Karnataka 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Chandana Vidya Shankar  Kasturba Hospital  Antenatal clinic Department of OBG Kasturba Hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA 
8105601617

chandanavidyashankar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O992||Endocrine, nutritional and metabolic diseases complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Physical Activity Counselling  Patients counselled by obstetrician to improve physical activity. These patients will be counselled during their regular antenatal checkup as per hospital protocols and intervention will continue till delivery 
Intervention  Standard Antenatal exercise protocol   structured antenatal exercise program prescribed by physiotherapist. Patient will continue exercise regimen as explained by the physiotherapist at home. These patients will be followed up during their regular antenatal check up at Kasturba Hospital. This intervention will continue till delivery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Pregnant women diagnosed to have GDM between 24-28 weeks 
 
ExclusionCriteria 
Details  1.Overt diabetes mellitus GDM diagnosed after 28 weeks
2.Any factor increasing the risk of preterm labor
3.Hemodynamically significant heart disease Restrictive lung disease
4.Incompetent cervix/cerclage
5.Multiple gestation at risk for premature labor
6.Persistent second or third trimester bleeding
7.Placenta praevia after 26 weeks gestation
• Ruptured membranes
• Pregnancy induced hypertension
• Non compliant to exercise protocol
• Non compliant to diet
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Glycemic Control  24-28 weeks
28 - 32 weeks
32-36 weeks
36 weeks to 40 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
WHO-GPAQ   8 weeks after intervention 
WHO-BREF  8 weeks after intervention 
Perinatal outcome  following delivery 
antenatal complications of GDM  24 weeks till delivery 
Route of delivery  delivery 
Intrapartum complications  during labour 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/04/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
RCT will be conducted at Antenatal Clinic, Kasturba Hospital, Manipal. Ethical clearance by Institutional Ethical Committee (IEC), Kasturba Hospital Manipal will be taken. Pregnant women who have been previously screened by the Obstetrician and confirmed with gestational diabetes mellitus (FBS 92mg/dl, 1hr 181mg/dl, 2hr 153mg/dl in 75gm of OGTT –According to IADPSG criteria) between 24-28 weeks of gestation will be enrolled for the study. They will be screened for inclusion and exclusion criteria through proforma where baseline demographic characteristics will be obtained. A written informed consent from the participants will be taken after a brief explanation about the procedure.

There are two accepted methods of increasing physical activity as a therapeutic measure to improve glycemic control among GDM mothers as practiced in our institution. One is a standard and structured antenatal exercise program prescribed by physiotherapist. Second is a counseling provided by the obstetrician on improving physical activity at home. Participants are divided into two groups, based on block randomization. In first group, participants receiving standard antenatal exercise protocol will be given a booklet describing the components of this structured exercise program. They will be given a detailed explanation on these exercises by a physiotherapist, along with some demonstration. Participants will be performing these exercises at home. Weights used will be personalized to patients condition. They would maintain a log book which would be scrutinized by the physiotherapist during their subsequent regular check ups. They would be motivated to ensure compliance, during these check ups. In the second group, treating obstetrician would give them a counseling on improvement on their routine physical activity at home and work place, along with some walking. 


All participants will be prescribed Medical Nutrition Therapy (MNT) according to maternal BMI and sugar levels, as per hospital protocol. Participants are given medications to achieve glycemic target if necessary, as deemed necessary by the treating obstetrician.


Periodic blood sugar levels are monitored as part of standard hospital protocol. Perinatal outcome including mode of delivery, ultrasound biometry, AFI, birth weight, neonatal outcome, and perinatal complications are noted down.  


Physical activity of all participants will be assessed based on WHO-GPAQ questionnaire, and quality of life will be assessed based on WHO-QOL BREF questionnaire before starting intervention and after 8 weeks of intervention. Physiotherapeutical intervention will continue till delivery.

Compliance to diet and exercise will be assessed during their regular visits.


 
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